FDA 510(k)

AYON 身体塑形系统® (AYON SYSTEM)

K号: K253396 · 2026-05-08

决定日期2026-05-08

产品代码QPB

咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。

决定实质等同

器械摘要

AYON Body Contouring System™ (AYON SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Apyx Medical Corporation. It received FDA 510(k) clearance on 2026-05-08 under 510(k) number K253396. The device is classified under product code QPB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AYON Body Contouring System™ (AYON SYSTEM)?

AYON Body Contouring System™ (AYON SYSTEM) is a medical device that received FDA 510(k) clearance on 2026-05-08. The listed applicant is Apyx Medical Corporation. The 510(k) number is K253396.

When did AYON Body Contouring System™ (AYON SYSTEM) receive FDA 510(k) clearance?

AYON Body Contouring System™ (AYON SYSTEM) received FDA 510(k) clearance on 2026-05-08, under 510(k) number K253396.

Who is the listed applicant for AYON Body Contouring System™ (AYON SYSTEM)?

FDA 510(k)记录列出了Apyx Medical Corporation为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for AYON Body Contouring System™ (AYON SYSTEM)?

The FDA product code for AYON Body Contouring System™ (AYON SYSTEM) is QPB.

列明Apyx Medical Corporation为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261710AYON™ Power Liposuction Cannulas和AYON™ Power Liposuction Cannula Adaptors K244050AYON 身体塑形系统 (AYON SYSTEM)K230586Renuvion® 微型手持器 K230272Renuvion® APR 手持器 K223262Renuvion® APR 手持器 K221830Apyx 一体机控制台

查看所有 7 个设备 →

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。